A  Prospec*ve  Randomized  Trial  Comparing   Percutaneous  Local  Abla*ve  Therapy  and  Par*al   Hepatectomy  for  Small  Hepatocellular  Carcinoma   RFS  Journal  Primer  

Quick  Summary   BOTTOM  LINE   • 

A   prospective   randomized   trial   on   180   patients   with   solitary   HCC   <5cm   found   percutaneous   local   ablative  therapy  (PLAT)  to  be  as  effective  as  surgical  resection.    

  MAJOR  POINTS     • 

The   1-­‐,   2-­‐,   3-­‐,   and   4-­‐year   overall   survival   rates   and   disease-­‐free   survival   rates   were   not   signiOicantly   different  between  the  PLAT  and  surgical  resection  groups.  

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Surgical  resection  had  more  major  complications  (50/90  patients)  vs  PLAT  (3/71)  

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Pain:  all  surgical  patients  required  analgesics.  Only  16  patients  required  analgesics  after  PLAT.  

• 

Longer  hospital  stay  for  surgical  patients  (19.70  vs  9.18  days).  

CRITICISM     • 

Post  randomization  exclusion  of  19/90  PLAT  patients.  Withdrew  consent.  

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Mean  follow  up  of  just  beyond  2  years.  

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Relatively  small  sample  size  (180  patients)  

Study  design   SINGLE  CENTER  PROSPECTIVE  RANDOMIZED  TRIAL   • 

180  patients:  90  received  PLAT,  90  had  surgical  resection:  Nov  1999  –  June   2004.  

INCLUSION  CRITERIA   • 

Age  18-­‐75  

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Solitary  HCC  <  5cm  in  diameter  

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No  extrahepatic  metastasis  or  major  portal/hepatic  vein  invasion  

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Pugh-­‐Child  Class  A  

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ICG-­‐R15  <  30%  

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Patients  suitable  for  either  intervention  

EXCLUSION  CRITERIA   • 

Previous  HCC  treatment  

• 

Platelet  count  <40,000,  history  of  encephalopathy,  ascites  refractory  to  diuretics,   variceal  bleeding  

 

Purpose   • 

To  compare  percutaneous  local  ablative  therapy  with  surgical  resection  in  the  treatment  of   solitary  and  small  hepatocellular  carcinoma.    

 

http://www.nature.com/modpathol/journal/v27/n3/Oig_tab/modpathol201380f5.html  

Interven7on:  RFA   Radiofrequency  Ablation   • 

RF  2000;  Radio-­‐Therapeutics,  Mountain  View,  Ca),  needle  electrode  with  15-­‐gauge  insulated   cannula  with  10  hook-­‐shape  expandable  electrode  tines  with  a  diameter  of  3.5  cm  at   expansion.  

• 

Local  anesthetics,  intravenous  sedation,  or  lumbar  epidural  anesthesia  

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Start  with  10  W  of  power,  increase  10  W/min  à  90  W  

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Apply  until  marked  increase  in  impedance  or  15  minutes  

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Up  to  3  applications  if  necessary  

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More  placement  of  needles  if  tumor  >3cm  or  initial  unsatisfactory  placement  

• 

Goal:  hyperechoic  area  covering  larger  area  than  HCC.  

  Follow-­‐up   • 

Dual-­‐phase  spiral  CT:  at  4  weeks  post-­‐op  à  every  2  months  for  Oirst  2years  à  ever  3  months  

• 

LFTs,  AFPs  at  each  visit.  Chest  X-­‐ray  every  6  months.  

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If  residual  viable  tumor,  additional  RFA  or  PEI.  

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If  still  present  after  repeat  treatments,  TACE  was  performed.  

Interven7on:  Surgical  Resec7on   • 

General  anesthesia  

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Right  subcostal  incision  with  midline  extension  

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Couinaud  liver  segment  resection:   •  1  segment  resection:  69  patients   •  2  segment  resection:  16  patients   •  3  or  more  segments:  3  patients  

• 

Goal:  resection  margin  of  at  least  1  cm  

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Clamp/unclamp  time  of  10  min/5  min.  

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Hemostasis  of  raw  liver  surface  with  suturing  and  Oibrin  glue  

Outcome

   

Intent-­‐to-­‐Treat:  19  PLAT  patients  withdrew  consent;  underwent  surgical  resection   • 

1-­‐,  2-­‐,  3-­‐,  and  4-­‐year  overall  survival  rates   •  PLAT:  94.4%,  79.8%,  68.6%,  65.9%   •  Resection:  93.3%,  82.3%,  73.4%,  64.0%  

• 

1-­‐,  2-­‐,  3-­‐,  and  4-­‐year  disease-­‐free  survival  rates     •  PLAT:  90.8%,  68.6%,  59.8%,  48.2%   •  Resection:  86.6%,  76.8%,  69.0%,  51.6%  

• 

No  signiOicant  difference  after  post-­‐randomization  exclusion  

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No  statistically  signiOicant  difference  in  overall  &  disease-­‐free  survival  between  the  two  groups  

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No  statistically  signiOicant  difference  in  overall  &  disease-­‐free  survival  when  analyzing  tumors   <3cm  and  3.1-­‐5.0  cm.  

  • 

Surgical   resection   major   complications   (50/90   patients):   Liver   failure,   GI   bleed,   moderate/ severe  ascites,  persistent  jaundice  >30  days  after  surgery.  

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PLAT  major  complications  (3/71):  mild  burn  at  electrode  pad  sites.    

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Pain:  all  surgical  patients  required  analgesics.  Only  16  patients  required  analgesics  after  PLAT.  

• 

Longer  hospital  stay  for  surgical  patients  (19.70  vs  9.18).  

Credits  

SUMMARY  BY:     Harout  Dermendjian  MS3   Keck  School  of  Medicine   University  of  Southern  California     FULL  CITATION:   Chen  MS,  Li  JQ,  Zheng  Y,  et  al.  A  prospective  randomized  trial  comparing  percutaneous  local  ablative  therapy  and  partial   hepatectomy  for  small  hepatocellular  carcinoma.  Ann  Surg.  2006;  243:  321-­‐328.  

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